Evaluation Of Novel Process Indicators For Rapid Monitoring Of Hydrogen Peroxide Decontamination Processes

By N.P. McLeod, M. Clifford, and J.M. Sutton

Validating vaporized hydrogen peroxide bio-decontamination processes in pharmaceutical production has historically relied on biological indicators. However, verifying the growth or inactivation of these bacterial spores requires up to seven days, which delays cycle development and routine re-qualification. Recent research highlights a viable alternative through an enzyme-based approach utilizing thermostable adenylate kinase. Because this robust enzyme shares a statistically correlated, biphasic inactivation profile with standard biological indicators, residual enzyme activity can be measured using bioluminescence within minutes of cycle completion. This provides immediate, fully quantifiable data regarding log-reduction performance, offering significant time and cost benefits over traditional microbiology methods.

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